August 25, 2010
The U.S. Food and Drug Administration (FDA), Center for Food Safety and Applied Nutrition (CFSAN) has scheduled a public hearing regarding the labeling of food made from AquAdvantage Salmon. AquAdvantage Salmon is a genetically engineered Atlantic salmon produced by AquaBounty Technologies, Inc. The hearing will be held on September 21, 2010 from 9:00 a.m. to 4:30 p.m. at the Hilton Hotel and Executive Meeting Center, 1750 Rockville Pike, Rockville, MD 20850, phone: (301) 468-1100.
The purpose of this hearing is for FDA to explain the relevant legal principles for food labeling and to solicit information and views from interested persons on the application of these principles to the labeling of food made from AquAdvantage Salmon. Additional details about the hearing are provided in a formal notice published in the Federal Register on August 26, 2010 and in a related Background Document: Public Hearing on the Labeling of Food Made from the AquAdvantage Salmon.
The hearing will include presentations from agency officials and members of the public. Due to limited space, we encourage all persons who wish to attend the hearing, including those who wish to make an oral presentation.
Questions regarding registration should be directed to: Syreeta Jones, BL Seamon Corporation, 9001 Edmonston Road, Suite 200, Greenbelt, MD 20770, telephone: (301) 577-0244 ext. 4900, fax: (301) 577-5261, e-mail: firstname.lastname@example.org.
For general information, if you need special accommodations due to a disability, or for requests to make an oral presentation, contact: Juanita Yates, CFSAN, FDA, telephone: 301-436-1731 (Updated contact number: 240-402-1731), e-mail: email@example.com. Please note the following important dates and instructions:
- September 8, 2010: Closing date for request to make an oral presentation
- September 13, 2010:
- Closing date for advance registration
- If requesting to make an oral presentation, provide a brief description of your presentation and any other written material related to your presentation.
- Submit any requests for special accommodations due to a disability.
- November 22, 2010: No later than this date, submit written comments on the labeling of food made from AquAdvantage Salmon to Docket No: FDA-2010 -N-0385, identifying your comments by this docket number. Submit electronic comments to http://www.regulations.gov, or submit written comments to the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
On September 19 and 20, 2010, FDA’s Center for Veterinary Medicine (CVM) will be holding a public Veterinary Medicine Advisory Committee (VMAC) meeting regarding the safety and effectiveness of the new animal drug that is the subject of a New Animal Drug Application concerning AquAdvantage Salmon. The VMAC meeting is a separate event apart from CFSAN’s public hearing.